Pharma Regulatory Conclave 2023: The Unique Inaugural Program Taking Bold Steps!

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Eminence Business Media

The Pharma Regulatory Conclave 2023, organized by Eminence Business Media, emerged as a trailblazing conference that prioritized knowledge acquisition and revitalization. This inaugural program established a remarkable standard by combining a one-day virtual session on June 30th with a two-day in-person conference at Hilton Resort in North Goa on July 5th and 6th.

With its distinctive theme on the second day, “Patrao,” the conclave incorporated dedicated question and answer rounds after each session, case study exercises, and the tranquil backdrop of Goa during the monsoon season. Notably, this regulatory program took bold strides by addressing existing challenges in the pharma regulatory industry while shedding light on the critical yet unexplored aspects of emerging markets.

The virtual day provided delegates with a theoretical understanding of various regulatory processes such as Regulatory Intelligence, Dossier Filings, and GDUFA III guidelines. Esteemed industry professionals like Mr. Prafulla Nandi from Cadila Pharma, Ms. Minoo Biju from Piramal Pharma Solutions, and Mr. Adam Freeman from exFDA Consultants delivered insightful presentations. Additionally, the program featured a captivating panel discussion with international experts representing regulatory bodies from the USA, South Africa, and Latin America.

Distinguished figures such as Mr. Larry Stevens from USFDA, Ms. Emtia Perold from SAPHARA, and Mr. Ivan Calderón from COFEPRIS shared their experiences and provided invaluable insights into the feasibility of establishing a common dossier for emerging markets. Esteemed personalities from the Indian Pharma industry, Dr. Udaykumar Rakibe from PharmaMantraTM and Dr. Sanjit Singh Lamba from Biocuris Pharma, also participated in the discussion, offering their perspectives on the global market.

The program’s unique design epitomized Eminence Business Media’s commitment to delivering excellence through learning. The virtual program seamlessly transitioned into the in-person conference, which featured an intriguing case study exercise focusing on the regulatory requirements of emerging markets. Mr. Rajeev Mathur from Sun Pharma designed this session, with Mr. Udaykumar Rakibe and Mr. Rahul Jain facilitating the exercise during the in-person conference. Delegates and attendees collaborated in groups, dedicating over a week to solve the case study and present their solutions on the second day of the conference. The group exercise yielded fruitful results, with delegates proposing innovative frameworks as solutions to the cases.

During the two-day in-person conference, a comprehensive exploration of topics took place, including regulatory requirements for complex generics, drug approvals in ICH countries, drug life cycle management, and post-approval changes, among others. Esteemed experts such as Mr. Rahul Gupta from USV, Ms. Meenakshi Jain from Sandoz, Ms. Vandana Singh from Biocon and Ms. Adity Sen Pal from Indoco Remedies delivered critical insights and actively engaged with the audience by addressing their questions.

Furthermore, Mr. Arani Chatterjee from Cadila Pharma and Mr. Praveen Cherukupalli from Innovare Labs delved into the regulatory requirements for clinical trials and nitrosamine, two key pain points for the industry. The in-person conference also featured a panel discussion moderated by Dr. Sanjit Singh Lamba, focusing on the ever-evolving challenges of regulatory affairs.

Eminence Business Media is preparing to unveil the schedule for the upcoming fourth edition of the Computer Software Assurance event in 2024.

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